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It is a prospective observational study.
Patients will be high risk patients (for developing cardiovascular events) that are treated with a statin. Patients will be enrolled at a normal clinic visit and provided with a small box containing info about the disease, a LDL self-test and two questionnaires. They will test themselves for LDL at home between normal clinic visits (normally 12 months interval) and note their value. In the end of the study all patients will fill out a questionnaire with questions if the tests and info have raised their awareness of the disease as well if their motivation to be compliant has increased.
We want to look at the possibility to put more responsibility for treatment and for reaching treatment goals on the patients since there's a big problem with compliance in this group of patients.
Consecutive patient sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperlipidemic Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid Self Test | Device | Self test for lipid levels, twice during study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 | Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test. | Month 12 |
| Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 | Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?". | Month 12 |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | Week 8 |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | Month 6 |
| Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | Month 12 |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. |
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Inclusion Criteria:
Aged 18 years or older and able to understand and sign the informed consent form.
Exclusion Criteria:
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Aged 18 years or older and able to understand and sign the informed consent form.
• Patients diagnosed with hyperlipidemia and a very high risk developing cardiovascular disease prescribed statin treatment according to clinical praxis and the recommendations set forth in the MPA national guideline for treatment of hyperlipidemia.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ã…kersberga | 184 27 | Sweden | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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A total of 259 participants were enrolled in the study, out of which 2 participants were not evaluated due to screening failure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Statins | Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Statins | Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Positive Response on Increased Motivation Using a Self-test at Month 12 | Participants with "Yes" response to a question which stated "The self-test have increased my motivation for taking my medication for hyperlipidemia?". The self test done for assessment of LDL levels using CARE diagnostica LDL-cholesterol test. | The Full Analysis Set (FAS) included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Statins | Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Week 8 |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | Month 6 |
| Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | Month 12 |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | Week 8 |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | Month 6 |
| Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | Month 12 |
| Forshaga |
| 667 32 |
| Sweden |
| Pfizer Investigational Site | Gothenburg | 405 30 | Sweden |
| Pfizer Investigational Site | Gothenburg | 415 10 | Sweden |
| Pfizer Investigational Site | Gothenburg | 41665 | Sweden |
| Pfizer Investigational Site | Höganäs | 263 36 | Sweden |
| Pfizer Investigational Site | Jönköping | 553 16 | Sweden |
| Pfizer Investigational Site | Lessebo | 360 50 | Sweden |
| Pfizer Investigational Site | Lilla Edet | 46330 | Sweden |
| Pfizer Investigational Site | Limhamn | 216 43 | Sweden |
| Pfizer Investigational Site | Malmö | 211 20 | Sweden |
| Pfizer Investigational Site | Oviken | 830 24 | Sweden |
| Pfizer Investigational Site | Partille | 433 34 | Sweden |
| Pfizer Investigational Site | Stockholm | 111 35 | Sweden |
| Pfizer Investigational Site | Täby | 183 30 | Sweden |
| Pfizer Investigational Site | Trollhättan | 461 53 | Sweden |
| Pfizer Investigational Site | Västerås | 722 11 | Sweden |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Positive response on self -estimated treatment compliance | Participants with "Yes" response to a question which stated "Have you been taking at least 90 percentage (%) of your medication for hyperlipidemia?" | Number | Percentage of participants |
|
| Low-density lipoprotein (LDL) lower than 2.5 millimole/liter (mmol/L) | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. The targeted level of LDL was lower than 2.5 mmol/L. | Number | Percentage of participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants With Positive Response on Increased Motivation After Awareness at Month 12 | Participants with "Yes" response to a question which stated "The awareness of my disease has increased my motivation for taking my medication for hyperlipidemia?". | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Week 8 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 8 |
|
|
|
| Primary | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 6 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants With Positive Response on Self-estimated Treatment Compliance at Month 12 | Participants with "Yes" response to a question which stated "Have you been taking at least 90% of your medication for hyperlipidemia?". | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Week 8 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 8 |
|
|
|
| Primary | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 6 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants With LDL Lower Than 2.5 mmol/L at Month 12 | LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Week 8 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | Percentage of participants | Week 8 |
|
|
|
| Primary | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 6 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | Percentage of participants | Month 6 |
|
|
|
| Primary | Percentage of Participants With Response Achieving Targeted LDL-cholesterol Level at Month 12 | Participants with "Yes" or "No" responses to a question which stated "Have you reached your target LDL-cholesterol level?". LDL levels were self-assessed by participants using CARE diagnostica LDL-cholesterol test. | The FAS included all enrolled participants who met all inclusion criteria. | Posted | Number | Percentage of participants | Month 12 |
|
|
|
| 7 |
| 259 |
| 0 |
| 259 |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Worsening of angina pectoris | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| Pancreatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.